Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:09 AM
Ignite Modification Date:
2025-12-25 @ 3:09 AM
NCT ID:
NCT03674905
Brief Summary:
Ankle arthritis is associated with debilitating pain and chronic disability. For the treatment of severe ankle arthritis, total ankle arthroplasty (TAA) is one treatment option. Postoperative pain management in joint arthroplasty is an ongoing and relevant issue. The purpose of this study is to examine if differences exist in postoperative pain control, overall patient satisfaction, and use of narcotics using an intra-articular injection in the operating room compared with a peripheral nerve block in patients undergoing TAA.
Detailed Description:
This is a two-arm, prospective, randomized, controlled clinical study. Use of intra-articular injections in TAA are not widely reported in literature; however, they are commonly used during total knee arthroplasty's (TKAs). The purpose of this study is to examine if differences exist in postoperative pain control, overall patient satisfaction, and use of narcotics using the intra-articular injection compared with a peripheral nerve block in patients undergoing TAA. Results will contribute to the literature for the best surgical practice for pain management following a TAA for ankle arthritis.
Patients will be randomized to receive one of the following interventions for pain control in the operating room:
1. Intra-articular Injection
2. Preoperative Peripheral Nerve Block:
The study aims are:
* Aim 1: Determine if intra-articular injection as source of pain control for TAA lowers postoperative pain as measured by self-reported narcotic use and pain vs. the peripheral nerve block.
* Aim 2: Evaluate differences in functional outcomes and health related quality of life between intra-articular injections and peripheral nerve block as reported by pre- and post-operative patient questionnaires
Patients who consent to participate will complete study activities pre-operatively, and at 2 weeks, 6 weeks, and 3 months post-operatively.
Study:
NCT03674905
Study Brief:
Protocol Section:
NCT03674905